MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Infusion or Flow Problem (2964)

Patient Problems Hyperglycemia (1905); No Code Available (3191)

Event Date 10/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).High blood sugar over 601 mg/dl [blood glucose increased], high a1c around 11% [glycosylated haemoglobin increased], high ketones tested at home with urine strip [urine ketone body present], pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder [incorrect dose administered by device], high blood sugars were due to the novopen echo cartridge holder [device issue].Case description: this serious spontaneous case from the united states was reported by a consumer (the patients mother) as "high blood sugar over 601 mg/dl" with an unspecified onset date, "high a1c around 11%" beginning on (b)(6) 2017, "high ketones tested at home with urine strip" with an unspecified onset date, "pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder" with an unspecified onset date, "high blood sugars were due to the novopen echo cartridge holder" with an unspecified onset date, and concerned a male patient born in (b)(6) who was treated with novopen echo (insulin delivery device) from unknown start date due to "diabetes mellitus".Patient's height, weight and body mass index: not reported.Medical history included diabetes mellitus (type and duration unknown).Concomitant products included - novolog penfill (insulin aspart) solution for injection, 100 u/ml, lantus(insulin glargine).It was reported that the pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder and on an unknown date, the patient experienced blood sugars over 601 mg/dl more than once, high ketones in urine.The patient had high a1c around 11% in (b)(6) 2017.The mother reported the high blood sugars were due to the novopen echo cartridge holder, but confirmed it was not cracked or broken.The patient did not require hospitalization and was being treated at home with non-carbohydrate fluids and treated with novolog injections every three hours with sliding scale.At the time of report, the patient was recovering.Action taken to novopen echo was not reported.The outcome for the event "high blood sugar over 601 mg/dl" was recovering/resolving.The outcome for the event "high a1c around 11%" was recovering/resolving.The outcome for the event "high ketones tested at home with urine strip" was recovering/resolving.The outcome for the event "pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder" was not reported.The outcome for the event "high blood sugars were due to the novopen echo cartridge holder" was not reported.Company comment: batchfvg7458-3 is included in recall (b)(4)) - cartridge holder issue.

Event Description

Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugar over 601 mg/dl" with an unspecified onset date, "high a1c around 11%" beginning on (b)(6) 2017, "high ketones tested at home with urine strip" with an unspecified onset date, "pen might not administer the insulin correctly or not giving the correct amount due to the recalled cartridge holder" with an unspecified onset date, "high blood sugars were due to the novopen echo cartridge holder" with an unspecified onset date, and concerned a (b)(6) year-old male patient (age at the time of reporting) who was treated with novopen echo (insulin delivery device) from unknown start date due to "diabetes mellitus", investigation results: name: novopen¿ echo¿, batch number: fvg7458-3.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Manufacturer's comment: batch fvg7458-3 is included in recall ((b)(4)) - cartridge holder issue.As the device (novopen¿ echo¿) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4).Evaluation summary: name: novopen¿ echo¿, batch number: fvg7458-3.(b)(4): the product was not returned for examination.The batch documentation was reviewed no abnormalities relating to the observed problem were found.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd 2880, ; DA
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 7058486
• MDR Text Key: 92903157
• Report Number: 9681821-2017-00060
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: FVG7458-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 00000-7/3/17-001-R
• Patient Sequence Number: 1
• Treatment: 1) NOVOLOG PENFILL (INSULIN ASPART),; 2) LANTUS (INSULIN GLARGINE).
• Patient Outcome(s): Other
• Patient Age: 10 YR